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临床试验/NCT07581223
NCT07581223尚未招募不适用

Integration of a Hydronephrosis AI-Driven Decision-Making Tool Into Clinical Practice: A Clinical Trial

The Hospital for Sick Children0 个研究点目标入组 322 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
322

研究概览

简要总结

Hydronephrosis is a common congenital kidney anomaly. While most cases resolve on their own, some require surgery. Clinicians rely on repeated ultrasounds and sometimes invasive tests to decide if surgery is needed, but predicting outcomes is difficult. Researchers at SickKids developed an AI model that analyzes ultrasound images to assist in diagnosing and managing hydronephrosis. This study tests how well the AI integrates into real-world care. Clinicians will first make care decisions without AI and then review the AI's prediction before deciding whether to change their plan. A separate expert, unaware of whether AI influenced the first clinician's plan, will make the final decision to ensure care remains unchanged. The study will assess whether AI improves decision-making, reduces unnecessary tests, and fits into clinical workflows. If successful, the AI model could serve as a complementary tool to make diagnoses more efficient and precise while minimizing invasive procedures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

This study will be a partially blinded trial as a third blinded clinician who makes the final clinical decision will be unaware if and what changes were made after clinician exposure to the AI model. Since, standard of care is maintained, patients will not be aware of the impact of the AI model

入排标准

年龄范围
0 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Seen for HN in-person in the Pediatric Urology clinic with ultrasound scans taken at SickKids
  • New and follow-up patients 0-24 months.

排除标准

  • Older than 24m
  • Concurrent urinary tract anomalies (duplex configurations; PUV etc.)
  • History of renal surgical intervention (post-op patients)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mandy Rickard

Nurse Practitioner

The Hospital for Sick Children

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